BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE

    MDR report key: 6702467 · Received July 11, 2017

    Report

    Report Number
    2029214-2017-00883
    Event Type
    Injury
    Date Received
    July 11, 2017
    Report Date
    June 15, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLOW DIVERTER DEVICE WERE NOT RETURNED FOR ANALYSIS AS THEY WERE IMPLANTED IN THE PATIENTS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, OUR ATTEMPTS WERE UNSUCCESSFUL. THE FLOW DIVERTER WERE REPORTED TO HAVE PERFORMED AS INTENDED, AS INDICATED BY SUCCESSFUL DEPLOYMENT OF THE DEVICE WITHIN THE INTENDED LOCATION. THROMBOEMBOLISM IS A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND IS DOCUMENTED IN THE PIPELINE INSTRUCTION FOR USE. THE CAUSE OF THE LOCAL THROMBUS FORMATION CANNOT BE RELIABLY DETERMINED; HOWEVER, PER THE REPORTED INFORMATION, REVIEW OF IFU, AND REVIEW OF LITERATURE, THE MOST LIKELY CAUSE FOR THE COMPLAINT IS PATIENT CONDITION. LINKED MDR EVENTS: 2029214-2017-00883, 2029214-2017-00884.

    Description of Event or Problem · 1

    CITATION: ENDOVASCULAR TREATMENT OF ACUTE INTERNAL CAROTID ARTERY DISSECTIONS: TECHNICAL CONSIDERATIONS, CLINICAL AND ANGIOGRAPHIC OUTCOME¿ WIEBKE KURRE, & KAI BANSEMIR, MARTA AGUILAR PÉREZ, ROSA MARTINEZ MORENO, ELISABETH SCHMID, HANSJÖRG BÄZNER, HANS HENKES. NEURORADIOLOGY (2016) 58:1167¿1179 DOI 10.1007/S00234-016-1757-Z MEDTRONIC RECEIVED REPORT THAT NEW THROMBUS FORMATION OCCURRED IN 13 PATIENTS. IN 6 CASES, IT WAS OBSERVED INSIDE THE STENT. IN 2 OCCASIONS IN THE IMPLANTED FLOW DIVERTERS AS WELL AS CAROTID STENTS. THROMBUS FORMATION WAS SUCCESSFULLY MANAGED BY INTRA-ARTERIAL INFUSION OF GPIIB/IIIA INHIBITORS, IMPLANTATION WITH OF FURTHER STENTS OR FLOW DIVERTERS, ANGIOPLASTY AND THROMBECTOMY OR A COMBINATION OF THESE MEASURES. THROMBUS FORMATION GAVE RISE TO A NEW INTRACRANIAL EMBOLIC VESSEL OCCLUSION REQUIRING THROMBECTOMY IN ONE OCCASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480641 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention